Improving Risk Prediction in Non-ischemic Cardiomyopathy (NICM): An Individualized Multimodality Approach Registry, Biobank and Imaging Data Repository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Time to first sustained ventricular arrhythmia
研究概览
简要总结
The main goal of CaNICM is to create a central database that includes a biobank and an imaging data repository for patients with non-ischemic cardiomyopathy (NICM), as well as for at-risk family members. This includes people who carry rare genetic variants linked to NICM but do not show symptoms, and first-degree relatives.
The specific goals of this database and biobank are to:
Enhance investigators' ability to predict the risk of heart rhythm disorders in patients with NICM.
Optimize the timing and approach for screening family members who may carry the disease - determining who to test, when, and how.
Find the best ways to treat family members early to prevent or slow the disease.
Future Phase - Phase 2 Goal:
- Prospectively evaluate how well this risk prediction model works in real-life clinical settings, and compare it to the current approach, which is often based on a single risk factor.
详细描述
PATIENT ENROLLMENT:
Eligible patients will be included from collaborating centres. Patients will be contacted by the local investigator or a research coordinator. Willing individuals will be interviewed by the research coordinator and given information about biobank. The consent form will be reviewed and discussed with the coordinator. The investigators will also be available for any questions that the coordinator is unable to answer. Potential participants will have sufficient time to consider participating in CaNICM. Written informed consent will be obtained from eligible patients or legal guardians. Participants will be able to withdraw their participation at any time.
BASELINE DATA COLLECTION:
Clinical data will be collected from consented participants from the electronic medical report and a questionnaire. Images including CMR and Transthoracic echography (TTE) will be collected. ECG in the XML format will also be transferred. Blood samples will be collected for biobanking
Healthcare information will be coded in compliance with Tri Council Policy Statement criteria: direct identifiers will be removed and replaced with a unique study code (research CaNICM ID that does not use personal information such as the participant's health number, social insurance number or name. The coded data will be transferred into the clinical research database using a web-based electronic case report form (eCRF), using Redcap. The clinical research database will be hosted and managed at the Montreal Heart Institute Research center. The research ID uniquely identifying each subject eCRF within the database will be attributed by the research team but the master list of registry participants with their study identifiers will be kept separately from the clinical research database. This master list will be stored in an encrypted file within the research office of each site investigators under their supervision. Only the site investigators and their local research staff will have access to this list.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LVEF <50% and/or
- •LVEF 50-55% with presence of clinically significant late gadolinium enhancement or LV dilatation and being carrier of a non ischemic cardiomyopathy causing gene (Pathogenic or likely pathogenic variant in a Clingen moderate or definite gene)
排除标准
- •A significant other cause of decreased LVEF such as:
- •Coronary artery stenosis (Significant lesion on proximal Left anterior descending or Left main, or ≥2 main branches with stenosis. Significant lesion is defined as >70% of any artery or >50% for the left main artery) or prior history of type 1 myocardial infarction
- •Significant congenital heart disease requiring intervention
- •Primary valvular disease including moderate to severe aortic stenosis and moderate to severe mitral stenosis, primary severe mitral regurgitation (secondary valvular disease such as mitral regurgitation/tricuspid regurgitation are not exclusion criteria)
- •Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
- •Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
- •Clear history of burned out hypertrophic cardiomyopathy
- •Already had a transplantation at time of first CMR
- •Refusal to provide informed consent
- •Additional remarks:
- •Patients aged > 70 years of age at first contact with a cardiologist regarding the cardiomyopathy will be limited to maximum 10% of the total enrolled patients by center.
- •Patients with risk factors (for example, chemotherapy, radiotherapy, alcohol...) for cardiomyopathy are not excluded unless they are deemed to completely account for the phenotype per the treating physician.
- •The inclusion is not restricted to adult patients and is planned to be extended to the pediatric population.
- •All included patients are recommended to have a CMR performed within 3 years of inclusion.
结局指标
主要结局
Time to first sustained ventricular arrhythmia
时间窗: 5 years
Spontaneous sustained VT ICD intervention (shock or antitachycardia pacing) Aborted sudden cardiac arrest (SCA) Sudden cardiac death (SCD)
Time to first life-threatening ventricular arrhythmia
时间窗: 5 years
defined as VT with a cycle length ≤ 240 ms (≥250 bpm)
Time to (aborted) sudden cardiac death in non-ICD carriers
时间窗: 5 years
Atrial fibrillation and thromboembolic events:
时间窗: 5 years
Atrial fibrillation Stroke or systemic embolism
次要结局
- Number of hospitalization or emergency visit for worsening heart failure(5 years)
- Rate of end-Stage HF(5 years)
- Number of clinical HF(5 years)